FDA Update on Breast Implant-associated Lymphoma and Illness
The FDA issued an update to its breast implant safety pages on August 20, 2020 regarding adverse events reported to the agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as well as data regarding “Breast Implant Illness” (BII).
The BIA-ALCL update showed that a total of 733 unique cases of BIA-ALCL and 36 patient deaths had been reported globally, representing an increase in 160 new cases (64 from the United States) and 3 deaths since the July 2019 update. BIA-ALCL occurs almost exclusively in patients who have breast implants with textured surfaces. If you are considering getting a textured-surface implant, you should discuss this with your healthcare provider and consider the risks associated with textured-surface versus smooth-surfaced implants.
The FDA update called for no changes in the recommended routine follow-up care for patients with breast implants.
The FDA also updated its data on Medical Device Reports (MDR’s) which were received pertaining to systemic signs and symptoms referred to by some patients as BII. The FDA received 2,497 medical device reports containing symptoms consistent with BII from November 2018 to October 2019, while the agency reported only 1,080 reports of such symptoms in the previous 10-year period. It was not noted whether this increase was due to more active monitoring of and reporting of such symptoms. The FDA noted that it does not have definitive evidence that breast implants cause these symptoms; however current evidence supports that some patients experience systemic symptoms that may resolve when their breast implants are removed.
1Excerpts from FDA issues BIA-ALCL update, Plastic Surgery News, American Society of Plastic Surgeons, September 2020.